Package for sterile storage of surgical devices and accessories



Jan. 2, 1968 H. c. R. LONHOLDT 3,361,253

- PACKAGE FOR STERILE STORAGE OF SURGICAL DEVICES AND ACCESSORIES Filed Oct. 25, 19 66 4 Sheets-Sheet 1 1968 H. c. R. LONHOLDT 3,361,253

PACKAGE FOR STERILE STORAGE OF SURGICAL DEVICES AND ACCESSORIES Filed Oct. 25, 1966 4 Sheets-Sheet PACKAGE FOR STERILE STORAGE OF SURGICAL Jan. 2, 1968 H c R LONHCLDT 3,361,253

DEVICES AND ACCESSORIES Filed 001:. 25, 1966 4 Sheets-Sheet 5 Jan. 2, 1968 H. c. R. LONHOLDT 3,361,253

PACKAGE FOR STERILE STORAGE OF SURGICAL, DEVICES AND ACCESSORIES Filed Oct. 25, 1966 4 Sheets-Sheet 4 United States Patent ()fil'ice 3,361,253 PACKAGE FOR STERILE STQRA GE GE SURGICAL DEVICES AND AKICESSORIES Hans Christian Ronnow Lonholdt, Espergaerde, Denmark, assignor to Move Terapeutisk Lahoratorinm, A/S, Qopenhagen, Denmark Filed Oct. 25, 1966, Ser. No. 589,312 3 Claims. (Cl. 2 l6--63.2)

ABSTRACT OF THE DISCLOSURE 10 A package for sterile storage of surgical devices in which an envelope is formed from preferably a single sheet of flexible material having two innermost adjacent portions folded defining sidewalls of the envelope which has a closed bottom along a fold between the two portions which are substantially of equal size. The sidewalls are joined along confronting extreme marginal edge portions for a selected distance from the bottom of the envelope and have respective continuations thereof reversely folded outwardly and extending beyond the sidewalls of said envelope defining flaps outwardly of said envelope and having confronting marginal edge portions along an extremity thereof joined to one another outwardly of and below the bottom of the envelope with said envelope disposed bottom down. One of the flaps has two slits disposed in respective planes substantially normal to said bottom dividing the one flap into three strips comprising an intermediate strip having a marginal end portion along an extremity thereof joined to the envelope along the bottom thereof. The intermediate strip thereby defines pulling means pullable in a direction generally upwardly away from said bottom of the envelope so that the sidewalls are effectively spaced from one another and open the envelope for easy removal of a surgical device cautioned therein without having to touch the envelope anywhere adjacent the interior thereof.

In surgery it is known to use a series of different devices, accessories and auxiliaries. The demand on sterility of such devices and auxiliaries is still increasing. Among them may e.g. be mentioned suture and ligature materials, peans (haemostatic forceps), wound retractors and wound clips, knives, scissors and forceps.

As far as a series of the said devices and auxiliaries are concerned, sterilization takes place in the hospitals, preferably by autoclaving. The devices or auxiliaries having been wrapped separately or several together are placed in a tray or bowl which is placed in an autoclave and is autoclaved. This applies e.g. to peans( haemostatic forceps), wound retractors and wound clips and to knives and scissors. The sterilized articles are then removed at the exact moment when they are to be used or they are put in unwrapped condition on the operating table in such case where they are to be at disposal at very short notice.

Other devices, such as suture and ligature materials with appertaining needles, if any, are sterilized on an industrial basis outside the hospitals. Thus, they are presented in sterile sealed packages which are to be opened before use.

The present invention relates to a package for sterile 3,361,253 Patented Jan. 2, 1968 storage of suture and ligature materials, peans (haemostatic forceps), wound retractors, knives, and other surgical devices and auxiliaries, and the object of the invention is to provide a package which on one hand reduces the danger of infection due to contamination of the sterile surgical devices and auxiliaries prior to their use and on the other hand renders possible an easy and quick. removal of the devices and auxiliaries from the packages.

The package according to the invention has a bag or envelope which is destined for receiving the surgical devices or auxiliaries. At its open end said bag has sidewalls which are slit up so as to form flaps which can be bent from each other for opening the bag and taking out the said devices or auxiliaries, and the characteristic feature of the package according to the invention is that at least one flap is connected with a stripped pulling means which extends downwards towards the sealed bottom of the bag where it is secured in such a manner that when displaced it can push the flaps out to the side.

If the package according to the invention only consists of the said bag, in the following called the flap bag, and the pulling means connected to it, the package is to be used in such cases where the surgical devices are sterilized in the hospitals. The said devices are placed separately or several together in a flap bag of suitable size and the bags are placed in a bowl or a tray and are sterilized by autoclaving. When said device or devices is or are to be used, one seizes the bottom of the flap bag, the bottom is turned downwards, the pulling means is activated and one or both flaps are moved out to the sides, which provides an easy and free admission to the contents of the bag. In this manner a real unwrapping of the sterile device immediately prior to use is avoided, and there is only slight danger of the device being made unsterile, since it does not come into contact with the vouter face of the flap bag which might have become unsterile.

For storage of suture and ligature material and other devices which are only to be used on one occasion and the final sterilization of which is made on an industrial scale upon finished packing, the flap bag is placed in a sealed outer bag of a germ-tight material having its bottom adjacent the end of the outer bag destined to be opened. Thus, when the outer bag is opened by cutting or tearing, its opening turned upwards, the bottom of the flap bag will be apparent, and when seizing the bottom, pulling out the flap bag and, if necessary, turning the bag so that the fiaps point upwards, one will. by activating the above mentioned pulling means. be able to move the said flaps out to the sides so that the contents of the :bag will become easily and freely accessible for direct use. In this manner the contents of the flap bag will not come into contact with the outer faces of the flap bag having touched the possibly unsterile edges of the outer bag, and it becomes unnecessary to carry out an additional tearing or cutting in order to get access to the sterile surgical device in the inner bag, such as has previously been the case.

It is a fundamental advantage of the package according to the invention that the flap bag is opened by seizing the bottom of the flap bag with one or both hands. Thereby it is avoided that germs, if any, from the fingers or from the palm of the hand can get access to the interior of the flap bag and thereby contaminate the contents of the bag. Ac-

3 cording to the packages known up to now one has always seized the flaps or an extension thereof with the fingers and torn the flaps out to the side.

By this mode of opening, some of the fingers and both of the palms are positioned immediately above the opened flap bag, whereby a contamination of the contents of the flap bag may take place if the hands are not completely sterile since germs from the fingers or the palms may fall down into the contents.

According to an embodiment of the package of the invention, the pulling means may consist of a folded strip which at the foot surrounds the bottom of the bag and at the top is connected with the flaps, preferably with the free edges thereof. When the strip surrounding the bag is grasped on both sides of the bag and is displaced, both flaps of the bag will move out to the sides. Thus according to this embodiment one obtains more easily access to the contents of the flap bag.

When the pulling means consists of a folded strip, this strip may according to the invention on one side be split up to form a middle strip and two side strips, and the ends of the latter are bent and secured to the other side of the strip. By this construction, when displacing the middle strip upwards in the direction of the open end of the bag, a displacement at right angles to the uppermost edge of the flaps is ensured. A prompt and safe opening of both of the flaps in thus obtained. Moreover, according to said construction it is most appropriate that the free end of the middle strip be bent round the bottom of the flap bag so that this free end will lie between the flap bag and the other side of the strip surrounding the flap bag. It is hereby ensured that the bottom of the flap bag is moved upwards when the middle strip is displaced upwards, so that the flaps of the bag with certainty are moved out to the sides.

In the production of the flap bag it is appropriate to use transparent foils of plastics which can be welded together by heating, e.g. by high frequency welding. As examples of suitable plastics may be mentioned ethylcellulose, cellulose acetate, cellulose propionate, cellulose acetate butyrate, polyamides, such as polyamino undecanoic acid, polyvinyl compounds, polyesters, polyethylene, polypropylene, polymonoohlorotrifluoroethylene and polytetrafluoroethylene. Use may also be made of laminates of two or more of the said plastics or of these and a metallic foil, e.-g. aluminum foil. Further, metal foils and papers, such as parchment paper and laminates hereof, are also applicable.

If the flap bag is used together with a sealed outer bag of germ-tight material, the latter may also be made from the same material as the flap bag. If the package according to the invention is used for sterile storage of suture or ligature material requiring a conditioning during the storage period by the presence in the package of a watercontaining moistening agent being or the vapours of which being in contact with the suture or ligature material, the sealed outer bag should be prepared from a material being impermeable or difficultly permeable to the vapours of the employed moistening agent. Suitable materials for said purpose are foils produced from appropriate laminates of the above mentioned plastics or foils of nylon, polymonochlorotrifluoroethylene, polytetrafluoroethylene or polyethylene glycolterephthalates. The sealed outer bag may also be produced from a laminated metallic tfoil, e.g. an aluminum foil being coated at its inner face with a thin film of polyethylene or other plastic which may be welded by the action of heat, and at its outer face with a thin layer of paper.

When selecting the material for the package according to the invention regard should be paid both to the manner in which sterilization is to be used and to the purpose for which the package is intended. Some plastics, slich as polyethylene are not suitable when sterilization takes place by autoclaving. When the package according to the invention is used for sterile storage of suture and ligature materials in the presence of a water-containing moistening agent, it is of course necessary that the employed materials are not affected by the moistening agent, and that the outer bag is impermeable thereto. The flap bag may be produced from a material permeable to the moistening agent and its vapours, such as polyethylene, particularly when the moistening agent is placed in the space between the flap bag and the sealed outer bag. This is, however, not absolutely necessary since the vapours of the moistening agent can penetrate into the flap bag through the slitup side-walls.

The invention is more fully explained in the following, reference being made to the drawings, in which:

FIG. 1 shows a front view of an embodiment of the package according to the invention,

FIG. 2 shows a perspective view of the same in opened condition,

FIG. 3 shows a front view of another embodiment of a l'la p bag for use in the package according to the invention,

FIG. 4 shows a perspective view of the same in opened condition,

FIG. 5 shows a diagonal front view of a third embodiment of the flap bag in partly opened condition, for the package according to the invention,

FIG. 6 shows a front view of a fourth embodiment of the flap bag,

FIG. 7 shows a perspective view of the same in opened condition,

FIG. 8 shows partly in section a front view of a package according to the invention with a fifth embodiment of the flap bag,

FIG. 9 shows the flap bag of FIG. 8 with no contents, seen in perspective in opened condition,

FIG. 10 shows in reduced scale, a body for producing the flap bag shown in FIGS. 8 and 9,

FIG. 11 shows in perspective the body shown in FIG. 10 in partly folded condition,

FIG. 12 is an outline showing the principle in folding the body shown in FIG. 10, and

FIG. 13 is a similar outline of the said principle showing a modification of a detail.

In FIGS. 1 and 2, 1 designates a bag made from a foil of plastic, by bending the foil for the formation of a fold 2 which serves as the bottom of the bag and welding the side edges for the formation of scaled side-walls 3 which extend over about one half of the length of the bag. How far in height the bag should be sealed in the sidewalls depends on the surgical device destined to be contained.

The one side-wall of the bag has an extension in the form of a strip 4, which is slightly narrower than the side-wall and which is folded back so that it extends almost completely down to the bottom of the bag 1. The extreme edge of the strip 4 is secured to the outer side of the wall of the bag. The strip has a circular swelling at the bottom for the formation of a fingergrip 5.

In the bag 1 is disposed a surgical device which in the embodiment shown constitutes a surgical knife blade 6, but which may be any other device, the size of the bag and the length of the open part of the side-walls of the bag being adapted to the size and form of the surgical device to be stored in the bag.

When the bottom of the bag is seized and in the region of the fingergrip 5 the strip 4 is led downwards, the bag opens as shown in FIG. 2. Moreover the bag can be used in the following manner:

The surgical device or devices to be sterilized is or are placed in the bag which is dimensioned to suit the size and form of the device in question, and the bag is placed in a bowl, tray or other receptacle and is autoclaved or sterilized in another manner. When the sterile device is to be used, one seizes with one hand the bottom of the bag and when pulling the strip 4, the bag will open so that there is free access to the device in the bag.

In will be seen that at no time the sterile surgical device comes into contact with the outer surfaces of the bag so that there is no danger of the device becoming unsterile even if for some reason or other the outer surfaces of the bag have lost their sterility. Further, it will be seen that the sterile device becomes directly and easily accessible for the operator without having been in the hands of any other person. Finally, it will be seen that the hand which opens the bag, seizes the bottom of the bag and is covered by the outwardly bent flap. Hereby it is ensured that germs, if any, from the palm of the hand and the fingers will not fall into the interior of the bag and thereby contaminate its contents.

In FIGS. 3 and 4, 7 designates a suture thread of silk or nylon coiled up into a ring and held together by means of a slip of paper 8 on which information as to type and length of the thread may be printed. Instead of the slip of paper 8, use may also be made of a wrapping or a packing of the thread in filtering paper or the like material. The thread is placed in a bag of similar construction as the bag 1 in FIGS. 1 and 2, the bag being provided with a bottom fold 2, welded side-walls 3 and flaps 9. The bag 1 is surrounded by a strip which extends from the one end of the edge of flap 9 to which it is secured, down to the bottom of the bag and up the other side of the bag to the edge of the other flap 9 to which it is also secured. The strip 10 has a slot 11 in front which extends from the bottom of the bag towards the flap 9 of the bag and have weldings 12 on the sides near the bottom of the bag is seized so that one of the fingers will lie against the fingergrip 5 of the bag and the bag is displaced upwards, the flaps 9 will move out to the sides so that there is free access to the interior of the bag.

For practical use the bag of FIGS. 3 and 4 is disposed in a sealed outer bag, as will be explained later in connection with FIG. 8. By opening the outer bag, access is ob tained to the bottom end of the inner bag and by taking out the bag and subsequently displacing upwards the bag at the strip 10, the bag will open.

In the embodiment shown in FIGS. 3 and 4 both flaps of the bag will move out to the sides, whereby access to the interior of the bag is more easily obtained.

The bag of FIG. 5 which is of a similar construction as that of FIG. 1 is in a similar manner as in FIG. 4 surrounded by a strip 13 having a finger-grip 5, but this strip narrows downwards in the direction of the bottom of the bag so that most of one side of the bag will be left free. When the said bag is to be opened, the operator seizes with the fingers of one hand the side of the bag having been left free, while with the fingers of the other hand he moves the strip 13 downwards, which causes the bag to open.

The bag of FIGS. 6 and 7 has, like the other bags, a bottom fold 2, welded side-walls 3 and flaps 9. On the outer side of each flap 9 a strip 14 is secured. The strip 14 on the one flap is led through a slot 15 in the bag and united with the strip 14 coming from the other flap 9. In the region where the two strips are united there is a fingergrip 5. When pulling the flaps 14 the bag will open, as shown in FIG. 7. Above the slot 15 is located a transverse welding seam 15 which seals the bag at the bottom.

In the embodiment shown in FIG. 8 the flap bag or envelope is disposed in a sealed outer bag which is made from two aluminium foils 16', which on the inner side are provided with a polyethylene or polypropylene layer and united with each other by means of weldings 17 along the edges. At the bottom of one side edge is disposed an indentation 18 by means of which a strip of the outer bag can easily be torn when the package is to be opened. Inside the fiap bag is placed a suture thread 7 of silk, nylon or catgut in a bag 8 The construction of the package appears best from FIGS. 9, 10 and 11, FIG. 10 showing the body from which the bag is made, FIG. 11 showing the bag or envelope during its assembling and FIG. 9 showing the bag in assembled and opened condition.

The body of FIG. 10 is a plastic length 18 or a length of the same material as the outer bag. (On this length there are provided fold-lines a, b, c and d crossing the length at right angles to its longitudinal direction. Moreover, notches or slits 20 have been made which extend from the one end of the length and almost to the fold-line c and run parallel to the side edges of the length at relatively short distance therefrom. Between the ends of the notches 20 a further fold-line 2 is made. Finally circular recesses are depressed so as to form fingergrips 5.

In preparing the bag from the length 18 in FIG. 10, the length is folded along the fold-lines a, b, c, d and e, as shown in FIG. 11. Hereby are produced side-strips 21 having bent ends 22, a middle or intermediate strip 23 with a bending 24, the side-walls of the: bag 25 and a back strip 26. When thereafter, e.g. by supplying heat, the ends 22 are glued to the reverse side of the back strip 26, and the lowermost part of the side-walls 25 of the bag along their edges is united, the finished bag will appear as shown in opened condition in FIG. 9, in which the open flaps of the bag are as before designated by 9.

The folding principle of FIG. 11 is shown in section in FIG. 12.

The finished package shown in FIG. 8 is opened, by first tearing the lowermost part of the outer bag at the indentation 18, after which the inner bag is seized in the region of the fingergrip 5, the inner bag is taken out and the middle strip 23 is displaced upwards, whereby the bag is opened and its contents can be taken out. It is also possible, before opening the package, to hold it in such a manner that the indentation faces upwards so that when the outer bag is torn and the inner bag is taken out, the inner bag is turned C. before opening it. In this way the danger of germs, if any, from the outer bag falling down into the inner bag is reduced.

FIG. 13 shows the modification of the embodiment shown in FIG. 12 consisting in that the lowermost edge 2'7 of the back strip 26 is bent inwards and is placed over the ends 22 in order to obtain better conditions for welding said parts.

The embodiments shown in the drawings are well suited for mass production since from an existing body length it is possible in a simple and easy manner to arrive at a package which can be opened with safety, even by unskilled persons. The flap can be made relatively small in size and its weight can be held down to a minimum which is a special advantage when sterilization of the package takes place by irradiation.

What I claim is:

1. A package for sterile storage of suture and ligature material, haemostatic forcets, wound retractors, knives, catheters and other surgical devices which comprises a single sheet of flexible material having two innermost adjacent portions folded defining sidewalls of an envelope having a closed bottom along a fold between said two portions and the sidewalls joined along confronting extreme marginal edge portions a selected distance from the bottom of the envelope, said sidewalls having respective continuations thereof reversely folded outwardly and extending beyond the sidewalls of said envelope defining flaps outwardly of said envelope and having confronting marginal edge portions along an extremity thereof joined to one another outwardly of and below said bottom with said envelope disposed bottom down, one of said flaps having two slits dividing said one flap into three strips comprising an intermediate strip extending juxtaposed relative one of said sidewalls and having a marginal end portion along an extremity thereof joined to said envelope along the bottom thereof, whereby said intermediate strip defines pulling means pullable in a direction generally upwardly away from the bottom of said envelope and effective to space apart the sidewalls and open the envelope for easy removal of a surgical device contained therein without having to touch the envelope anywhere adjacent the interior thereof.

2. A package according to claim 1, in which said two innermost adjacent portions of said single sheet of flexible material are substantially of equal size.

3. A package according to claim 1, in which said two slits are disposed in respective planes substantially normal to said bottom of said envelope and extend from one edge of said sheet terminate without extending to a reverse fold of said one flap.

References Cited UNITED STATES PATENTS Tanzi 229--11 Kursh 206-62 Von Rodeen 229-44 Schrom 20641.2 Lonholdt et a1. 206-633 WILLIAM T. DIXSON, JR., Primary Examiner. 

